Regulatory Affairs Manager Jobs

Kelly® Science & Clinical is seeking a Regulatory Affairs Manager for a direct hire opportunity with one of our clients, a leading animal health pharmaceutical company in the Kansas City area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $150,000-200,000 DOE

Workplace: Onsite, must be based in, or willing to relocate to, the Kansas City area.

Overview

Carry out and oversee regulatory activities to support the development, registration, and approval of new animal products under FDA/CVM by being a core team member on Global and US development teams. The primary emphasis is on Safety and Effectiveness, with a secondary emphasis on Chemistry, Manufacturing, and Controls.

Responsibilities

• Proactively monitor, evaluate, and communicate existing and new US regulations impacting products and projects. Assess the potential impact and/or opportunities.
• Serve as Regulatory Affairs, Global Development Team member that proactively provides regulatory strategies and pathways contributing to the optimal development, registration, and approval of new products. Able to lead and/or support project teams in this capacity as assigned.
• Coordinate technical input for preparation/review of FOI summary and label language for assigned projects.
• Subject matter expert on current US FDA/CVM regulatory requirements for new animal drugs, with a focus on Effectiveness and Safety, and candidates with additional knowledge of CMC being highly encouraged.
• Prepare regulatory assessments for project teams, line management, and key stakeholders as requested. Includes support for due diligence evaluations.
• Maintain database(s) for tracking regulatory correspondence, communications, submissions, critical dates, and commitments. Ability to effectively use FDA/CVM submission system (E-submitter)
• Interface with regulatory authorities on new product development and registration programs, as well as industry associations.
• Prepare timely, well-written regulatory submissions with appropriate content, organization, clarity, and completeness. Includes submissions for pre-development / pre-submission meetings, dossiers / technical sections, amendments, and reactivations. Accurate review and assessment of the suitability for prepared submissions.

Qualifications

• Ability to act as the organizational authority and established expert on interpreting, following up, and applying knowledge of registration and development directives. Ability to anticipate cause/effects during development and pre-submission.
• The primary emphasis is on Safety and Effectiveness, with a secondary emphasis on Chemistry, Manufacturing, and Controls.
• Ability to make impactful presentations in front of audiences including regulatory authorities, KOLs, and top management of the company. Ability to deliver vertical back-and-forth communication between management and project teams.
• Ability to apply expertise to act as the organizational authority on analyzing data from multiple sources to define appropriate Regulatory Affairs strategy and to make suitable recommendations.
• Capacity to work independently and provide guidance and training to others while interpreting, following up, and applying knowledge of efficacy, safety, and quality regulatory procedures.
• Ability to use FDA e-submission tools, archiving tools according to local requirements, and advanced use of main Microsoft Office suite tools and Adobe.
• Know-how of project coordination (tasks links and critical path, inter-project management). Ability to interpret timely financial impacts of Regulatory Affairs decisions on production, supply & marketing, and impacts on Summary of Product Characteristics and claims.
• Minimum of 10 years of pharmaceutical experience, with at least 5 years in FDA/CVM Regulatory Affairs responsibilities for the development and registration of veterinary drug products. Direct knowledge and proven experience that resulted in FDA drug approval(s). The ideal candidate has work experience in a wide array of drug development and registration topics (e.g., efficacy, safety, CMC, labeling, protocols for GLP and GCP studies, Human Food Safety, and adaptive design studies). Experience with biopharma products or other regulatory agencies governing animal products (e.g., EMA, EPA, USDA) is a bonus.
• High-level knowledge of registration dossier preparation for US FDA/CVM. Including development, drawing conclusions, and the effect of changes.
• Degree(s) in a relevant scientific field (BS/MS/Ph.D.) from an accredited institution with appropriate certification in Regulatory Affairs.

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.